ASQ March 2014 Roundtable – Risk Based Environmental Monitoring (EM)

This message is sent by the Southern California Discussion Group of the Biomedical Division of ASQ of the American Society for Quality as a benefit of your membership.

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The Southern California Discussion Group of the ASQ Biomedical Division Presents:

Risk Based Environmental Monitoring (EM)

How to use risk to ensure your EM Program is value added & efficient

An Industry Roundtable Discussion

Tuesday, March 25, 2014 5:30pm to 8:30pm

Topic:

Risk Based Environmental Monitoring and Efficiencies Gained With Use of an Automated System (Novatek)

Non-viable air, viable air, and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental Monitoring (EM) sample locations based on a grid approach of dividing up the rooms and taking samples inside all of the grids. Current regulatory requirements involve taking risk based approaches in the manufacturing of products, including Environmental Monitoring. Does your current EM Program consist of many floor and wall sample locations? Do you ever ask yourself if the data you are collecting every week/month/year in your EM Program is value added?

Current regulatory expectations are that your EM Program is based on risk of microbial contamination in your process. Formal risk assessments should be performed to justify your EM sample site locations and frequencies. In doing so, your EM Program will ensure that the data you are collecting is meaningful and can help to identify potential contamination problems in your products and processes. This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this session we will discuss how to set up a new Environmental Monitoring Program based on risk as well as how to perform a reassessment of your current Environmental Monitoring Program to re-establish sampling locations and frequencies based on results of your risk assessments coupled with the knowledge gained from your current EM Program historical data.

Once you have a risk based EM Program in place, you need to manage the data you are collecting. A great way to gain efficiencies is by using an automated system for environmental monitoring. The Novatek Environmental Monitoring data management and trending software system will be presented.

Takeaways: * How to perform an Environmental Monitoring risk assessment unique to your manufacturing process * Recent changes in guidance documents and regulations for EM Programs including contamination control rates, risk based sample selections and sampling frequencies * Learn how to optimize your EM Program with use of an automated system while gaining efficiencies

Please bring your questions, experiences, and other commentary to make this a more valuable experience.

Experts:

Marsha Stabler Hardiman

has over 20 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. Marsha is an expert in industrial Microbiology test methods from environmental monitoring (EM) and utility system microbial testing to intermediate product testing through final product sterility testing. Marsha also served as a Microbiology Expert – Notified Body regulatory inspector for CE certification of medical devices and has extensive knowledge in quality systems. Over her career, Marsha has established numerous EM programs for many different medical device and pharmaceutical companies.

Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board; is leading a PDA Task Force on Microbial Data Deviations; serves on the PDA Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting. Marsha also serves as a voting member on the ISO 14644 Liquid Chemical Sterilization Working Group.

Marsha is a Senior Consultant for Concordia ValSource and in this role helps companies implement quality risk management into their quality management systems and validation programs. Marsha currently helps companies reassess their existing EM programs and re-select sample locations based on risk

Cheryl Zaman-Zadeh, MS

is the Director of Technical Sales at Novatek International where she has been for over 15 years. She has played a key role in assisting many small and large organizations define their user requirements in order to fully automate their Environmental Monitoring process. She has experience in applying solutions to the Pharmaceutical, Medical Device, BioTechnology and Food Industry in the area of root cause analysis, the application of process improvement by virtue of continuous feedback loops, compliance, statistical analysis and risk based management.

She is an international presenter and has previously presented on topics of Environmental Monitoring and Quality Systems in various conferences such as Local California PDA, IVT, AOAC (southern California) and IPA.